Associate Director Biostatistics

Associate Director, Biostatistics | Hybrid, Greater London Area (UK)

Skills, Experience, Qualifications, If you have the right match for this opportunity, then make sure to apply today.

An innovative biotech company is seeking an Associate Director, Biostatistics to provide statistical leadership across clinical development programs. This individual will partner closely with cross-functional teams on study design, statistical analysis, data interpretation, and regulatory submissions.

Key Responsibilities

• Lead statistical strategy and support clinical development programs.
• Contribute to study design, protocol development, and statistical analysis plans.
• Collaborate with Clinical Development, Regulatory, Data Management, Clinical Operations, and Programming teams.
• Provide statistical guidance for ongoing studies and data analyses.
• Support clinical study reports, regulatory submissions, and scientific publications.
• Manage CRO statistical and programming activities.

Qualifications

• PhD in Biostatistics, Statistics, or related field with 7+ years of industry experience, or MS with 10+ years of relevant experience.
• Strong experience supporting clinical trials in a biotech or pharmaceutical environment.
• Proficiency in SAS and knowledge of clinical trial methodology.
• Excellent communication and cross-functional collaboration skills.

Preferred Experience

• Experience supporting late-stage clinical development and regulatory submissions.
• Lead statistician experience.
• Knowledge of CDISC standards (SDTM, ADaM).
• Experience with R and adaptive trial designs. xwzovoh
• Regulatory agency interaction experience.